EU307 / Eutilex - LARVOL DELTA

Eutilex, JP Morgan Bio Partnering Consults with 10 Global Innovative Technology Companies [Google translation] (BioTimes) - "Eutilex announced on the 22nd that it had held meetings with about 10 global innovative technology companies and investment-related companies from the US and Switzerland regarding the GPC3 target solid cancer CAR-T treatment 'EU307' and the VSIG4 target antibody treatment 'EU103'...Yutilex plans to accelerate the advancement of its ‘Armored CAR-T platform’ through cutting-edge technology collaboration with them...Yutilex also met with Professor Carl June of the University of Pennsylvania, who attended the forum event held during JP Morgan Week, and discussed the positive effect of its EU307 in the clinical trial of GPC3-expressing advanced hepatocellular carcinoma through Armoring IL-18."

Clinical • Hepatocellular Cancer

EU307 Clinical CI Professor Kim Do-young “GPC3 is highly expressed in metastatic cancer” [Google translation] (Hankyung) - "Yutilex announced on the 19th that it had presented a poster on the clinical design of its self-developed CAR-T treatment 'EU307' at the 2024 European Society for Medical Oncology (ESMO) held in Barcelona, ​​Spain...The primary objective of the clinical trial is to evaluate safety through dose-limiting toxicity (DLT) and adverse event evaluation and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)...EU307 passed the Safety Review Committee (SRC) for the first cohort and is currently administering the second cohort out of a total of four cohorts. The SRC reviews the safety data generated during the clinical trial and decides whether to proceed to the next stage....EU307 is expected to complete a total of four cohorts in the first half of 2025. The goal is to present interim results, including data, at a global conference in the first half of next year."

Clinical protocol • DSMB • P1 data • Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

First-in-human dose escalation trial of fourth generation chimeric antigen receptor (CAR) T cell therapy (EU307) in patients with glypican-3 (GPC3) positive hepatocellular carcinoma (HCC) (ESMO 2024) - P1 | "Patients undergo lymphodepletion with cyclophosphamide and fludarabine before receiving EU307 CAR-T cell infusion. Secondary objectives include evaluating preliminary efficacy using mRECIST criteria, and exploring the pharmacokinetic properties of EU307 and changes in immune cells. The study is currently underway at four institutions in South Korea, with enrollment of the first participant in September 2023 and recruitment expected to be completed by 2024."

Clinical • P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3 • IL18

Yutilex, 'Solid Tumor CAR-T Treatment' Selected for ESMO Green [Google translation] (HIT News) - "Yutilex...announced on the 16th that the abstract submitted as the clinical design for its solid cancer (hepatocellular carcinoma) CAR-T treatment 'EU307' was accepted at the European Society for Medical Oncology (ESMO) to be held in Barcelona, ​​Spain from September 13th to 17th...According to Yutilex, the clinical design was a multicenter phase 1 dose-escalation approach to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity. The clinical subjects included ‘patients with GPC3-positive advanced hepatocellular carcinoma who had failed standard therapy.'...The primary objective of the clinical trial is to evaluate safety through dose-limiting toxicity (DLT) and adverse event evaluation and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). The secondary objective is to evaluate preliminary efficacy using the mRECIST..."

Clinical protocol • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307 (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Eutilex | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2024 ➔ Dec 2025 | Trial primary completion date: May 2024 ➔ Jun 2025

CAR T-Cell Therapy • Enrollment open • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3 • IFNG • IL10 • IL18 • IL2 • IL6 • TNFA

Eutilex, solid cancer CAR-T treatment '307' signs KDDF support agreement [Google translation] (HIT News) - "Eutilex...'307', a 4th generation CAR-T treatment for patients with advanced hepatocellular carcinoma, is eligible for the 3rd new support in 2023 hosted by the National New Drug Development Foundation (Director Hyun-sang Muk, KDDF) It was announced on the 12th that the project has been selected and will receive research and development funding for two years."

Licensing / partnership • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Eutilex CEO Kwon Byeong-se appears as the first speaker at the 2024 ACGT [Google translation] (Eutilex Press Release) - "Eutilex Co., Ltd...CEO Kwon Byung-se appeared as the first speaker at the cell therapy session of the Biocon Asia 2024 Seminar (ADVANCED CELL&GENE THERAPY, ACGT) held in Singapore at 9 a.m. on the 13th (local time)....A Eutilex official said, 'It is meaningful to introduce ‘307,’ a CAR-T treatment targeting solid cancer beyond blood cancer, at a conference held in the Greater China region, including China, the largest CAR-T treatment market.'"

Clinical • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Eutilex begins recruiting clinical patients for hepatocellular carcinoma CAR-T treatment [Google translation] (HIT News) - "Eutilex (CEO Yoo Yeon-ho) announced on the 25th that it has started recruiting patients for the clinical trial of 'EU-307 (development code name)', a CAR-T hepatocellular carcinoma treatment. The recruitment target is 'GPC3' positive advanced hepatocellular carcinoma patients who have failed standard therapy."

Enrollment open • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

IL-18 secreting chimeric antigen receptor T cells targeting glypican-3show superior persistence and antitumor immunity against hepatocellular carcinoma (AACR 2023) - "In this regard, we report here that we have successfully developed a CAR-T cell therapy, referred to as EU307, to treat one type of solid tumor, hepatocellular carcinoma (HCC)...Furthermore, a single dose toxicity study in the same disease mouse model determined the no observed adverse effect level (NOAEL) as 5.0 X 105 total cells per male and 1.0 X 106 total cells per female. Taken together, our studies demonstrate that we have a developed a novel fourth-generation CAR-T therapy to treat HCC, a solid tumor that expresses a high-level of tumor-specific GPC3, by overcoming previously limiting factors in the development of CAR-T therapies against solid tumors."

CAR T-Cell Therapy • Late-breaking abstract • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3 • IL18

To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307 (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Eutilex

CAR T-Cell Therapy • Metastases • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

Eutilex makes 1st foray into homegrown CAR-T therapy testing (Korea Biomedical Review) - "Eutilex, a Korean biotech firm, said it would conduct a clinical trial to develope a home-grown chimeric antigen receptor T cell (CAR-T) therapy. The company said on Wednesday the Ministry of Food and Drug Safety approved its plan to test EU307, an investigational CAR-T therapy in hepatocellular carcinoma (HCC), in a phase 1 study. EU307 targets GPC3-positive solid cancer."

New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Eutilex to start Korea’s 1st clinical trial for CAR-T in treating solid cancers (Korea Biomedical Review) - "Eutilex said it would begin clinical trials for a CAR-T treatment to treat solid cancer for the first time in Korea. The company plans to submit an investigational new drug application (IND) for its CAR-T treatment pipeline in the second half of this year and has already secured non-clinical efficacy data. EU307 (GPC3-IL18 CAR-T treatment), the candidate set for IND application, targets GPC3, a substance overexpressed in 70-80 percent of liver cancer patients among solid cancers....'In addition to EU307, Eutilex will also apply for EU301 (MVR CAR-T treatment) targeting HLA-DR and apply a patent for EU309, a treatment targeting brain tumors'..."

New trial • Patent • Brain Cancer • CNS Tumor • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor